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Biomonitoring, which measures chemicals in people's tissues or body fluids, has shown that the U.S. population is widely exposed to chemicals used in everyday products. Some of these have the potential to cause cancer or birth defects. Moreover, children may be more vulnerable to harm from these chemicals than adults. The Environmental Protection Agency (EPA) is authorized under the Toxic Substances Control Act (TSCA) to control chemicals that pose unreasonable health risks. GAO was asked to review the (1) extent to which EPA incorporates information from biomonitoring studies into its assessments of chemicals, (2) steps that EPA has taken to improve the usefulness of biomonitoring data, and (3) extent to which EPA has the authority under TSCA to require chemical companies to develop and submit biomonitoring data to EPA.

EPA has made limited use of biomonitoring data in its assessments of risks posed by commercial chemicals. One reason is that biomonitoring data relevant to the entire U.S. population exist for only 148 of the over 6,000 chemicals EPA considers the most likely sources of human or environmental exposure. In addition, biomonitoring data alone indicate only that a person was somehow exposed to a chemical, not the source of the exposure or its effect on the person's health. For most of the chemicals studied under current biomonitoring programs, more data on chemical effects are needed to understand if the levels measured in people pose a health concern, but EPA's ability to require chemical companies to develop such data is limited. Thus, the agency has made few changes to its chemical risk assessments or safeguards in response to the recent increase in available biomonitoring data. While EPA has initiated several research programs to make biomonitoring more useful to its risk assessment process, it has not developed a comprehensive strategy for this research that takes into account its own research efforts and those of the multiple federal agencies and other organizations involved in biomonitoring research. EPA does have several important biomonitoring research efforts, including research into the relationships between exposure to harmful chemicals, the resulting concentration of those chemicals in human tissue, and the corresponding health effects. However, without a plan to coordinate its research efforts, EPA has no means to track progress or assess the resources needed specifically for biomonitoring research. Furthermore, according to the National Academy of Sciences, the lack of a coordinated national research strategy has allowed widespread chemical exposures to go undetected, such as exposures to flame retardants. The development of such a strategy could enhance biomonitoring research and link data needs with collection efforts. EPA has not determined the extent of its authority to obtain biomonitoring data under TSCA, and this authority is untested and may be limited. The TSCA provision that authorizes EPA to require companies to develop data focuses on the health and environmental effects of chemicals. Since biomonitoring data alone may not demonstrate the effects of a chemical, EPA may face difficulty in using this authority to obtain biomonitoring data. It may be easier for EPA to obtain biomonitoring data under other TSCA provisions, which allow EPA to collect existing information on chemicals. For example, TSCA obligates chemical companies to report information that reasonably supports the conclusion that a chemical presents a substantial risk of injury to health or the environment. EPA asserts that biomonitoring data are reportable if the chemical in question is known to have serious toxic effects and biomonitoring information indicates a level of exposure previously unknown to EPA. EPA took action against a chemical company under this authority in 2004. However, the action was settled without an admission of liability by the View GAO-09-353 or key components. company, so EPA's authority to obtain biomonitoring data remains untested.

Recommendations for Executive Action

Status: Closed - Implemented

Comments: According to EPA officials, the Office of Research and Development's Chemical Safety for Sustainability Research (CSS) Program implements EPA's integrated biomonitoring research which addresses the needs of EPA's Program Offices and provides science for EPA to respond to GAO's recommendations. These officials indicated that the main biomonitoring research priority within the EPA CSS program studies is not to engage in a chemical by chemical approach but to study how chemicals interact with humans and the environment, and what biomarkers and bioindicators of these interactions impact key biological events that lead to adverse effects. These adverse effects may be such things as reproductive and developmental toxicity and cancer. While EPA has identified the purpose of the research as identifying the biomarkers and bioindicators that are relevant to an adverse outcome pathway (AOP), these elements address the general intent of our recommendation. Agency officials indicated that. AOPs provide an approach to evaluating all the existing information concerning the linkage between an event at the molecular level and an adverse outcome at a biological level that may be relevant to risk assessment. They added that the identification of key biomarkers and bioindicators will be used to develop models to predict chemical exposure and hazard and to help evaluate chemicals for potential risks to human health and the environment.

Recommendation: To ensure that EPA effectively obtains the information needed to integrate biomonitoring into its chemical risk assessment and management programs, coordinates with other federal agencies, and leverages available resources for the creation and interpretation of biomonitoring research, the EPA Administrator should develop a comprehensive biomonitoring research strategy that includes the data EPA needs to incorporate biomonitoring information into chemical risk assessment and management activities, identifies federal partners and efforts that may address these needs, and quantifies the time frames and resources needed to implement the strategy. Such a strategy should (1) identify and prioritize the chemicals for which biomonitoring data or research is needed, (2) categorize existing biomonitoring data, (3) identify limitations in existing data approaches, (4) identify and prioritize data gaps, and (5) estimate the time and resources needed to implement this strategy.

Agency Affected: Environmental Protection Agency

Status: Closed - Implemented

Comments: According to EPA officials, the agency has identified federal partners and efforts that it can leverage to address the development of a comprehensive biomonitoring research strategy. By building on the recent National Academy of Sciences report on Exposure Science in the 21st Century, the Toxics and Risk (T&R) Subcommittee of the Office of Science and Technology Policy (OSTP)'s Committee on the Environment and Natural Resources (CENR) has established an interagency workgroup to examine priorities and opportunities for collaboration to address those priorities. EPA officials indicated that a charter is under review by the workgroup which will be chaired by EPA with vice chairs from CDC, NIEHS and DoD. Also, EPA is continuing its work under the agency's own Biomonitoring Workgroup comprised of senior scientists from the agency's program and regional offices. These officials indicate that EPA's meetings provide an opportunity to discuss CDC's Human Biomonitoring Program (as part of NHANES) as well as the status on chemicals in which the agency has an interest. These various coordination efforts address the intent of our recommendation to leverage available resources for the creation and interpretation of biomonitoring research.

Recommendation: To ensure that EPA effectively obtains the information needed to integrate biomonitoring into its chemical risk assessment and management programs, coordinates with other federal agencies, and leverages available resources for the creation and interpretation of biomonitoring research, the EPA Administrator should assess EPA's authority to establish an interagency task force that would coordinate federal biomonitoring research efforts across agencies and leverage available resources, and establish such a task force if it determines that it has the authority. If EPA determines that further authority is necessary, it should request that the Executive Office of the President establish an interagency task force (or other mechanism as deemed appropriate) to coordinate such efforts.

Agency Affected: Environmental Protection Agency

Status: Closed - Implemented

Comments: EPA officials indicated that as the agency considers the usefulness of biomonitoring data in specific contexts, it can determine the extent of its legal authority. These officials believe that assessment of its legal authority is necessarily context-specific. Whether EPA may require biomonitoring data may depend upon variables such as the nature of the data, how the data will be used, and how submission of such data may advance existing knowledge. Further, EPA officials stated that they can explain the basis for any data development and/or reporting requirement, consistent with the statutory requirement, in any regulatory action requiring such data. In considering the question of authority for requiring submission of biomonitoring data, EPA officials indicated that they believe that in many cases sufficient authority exists. Where a lack of authority regarding a data need is identified, EPA officials acknowledged the need to address questions regarding additional authority and the possibility of an assessment of EPA authority to collect such data, consistent with the general intent of our recommendation.

Recommendation: To ensure that EPA has sufficient information to assess chemical risks, the EPA Administrator should determine the extent of EPA's legal authority to require companies to develop and submit biomonitoring data under TSCA. EPA should request additional authority from the Congress if it determines that such authority is necessary. If EPA determines that no further authority is necessary, it should develop formal written policies explaining the circumstances under which companies are required to submit biomonitoring data.